Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Iloprost for Raynaud's Phenomenon Secondary to Systemic Sclerosis

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- * Raynaud's phenomenon secondary to systemic sclerosis (SS) SS meets American College of Rheumatology diagnostic criteria * At least 6 Raynaud's attacks per week --Prior/Concurrent Therapy-- * No prior participation in oral iloprost study * At least 4 weeks since participation in other investigational drug studies * At least 2 months since prostanoid therapy * At least 12 months since sympathectomy of upper limb * Ongoing therapy for systemic sclerosis may continue on study Raynaud's therapy discontinued at entry --Patient Characteristics-- Hematopoietic: No platelet disorder Hepatic: No bleeding diathesis Renal: Creatinine clearance (estimated) at least 30 mL/min Cardiovascular: No unstable angina pectoris None of the following within 3 months: * Stroke * Transient ischemic attack * Myocardial infarction Other: * No active cancer or other uncontrolled disease * No current history of alcohol or drug abuse * No mental disorder precluding compliance * No pregnant or nursing women * Negative pregnancy test required of fertile women * Adequate contraception required of fertile women